MAUDE Adverse Event Report: MEDTRONIC IRELAND ONYX FRONTIER; STENT, CORONARY, DRUG-ELUTING

Model Number ONYXNG30038UX

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2024

Event Type  Injury  

Event Description

An attempt was made to use an onyx frontier coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion with 90% stenosis in the distal right coronary artery (rca).The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.It was reported that stent dislodgement occurred during removal following a failed delivery. the dislodged stent was not removed.The device was not able to cross a distal lesion and upon retraction the stent stopped in the mid rca and could not be retracted any further.When the stent was stopped and stuck in the mid rca, while still on the balloon, it was noticed the stent had longitudinal stent deformation (lsd).A second coronary wire (cougar xt) was placed down the rca and the stent was retracted to the proximal rca.However, the stent would not enter into the guide catheter.At that point in the proximal rca, the stent dislodged off the balloon.A 1.5 balloon was placed inside the dislodged stent and inflated.Sequential larger balloons were then placed inside the stent, with the largest being an nc 4.5mm diameter to match the size of the proximal rca vessel.The stent was well apposed and sized to the proximal rca.A new 3.0x38mm onyx stent was then placed in the distal vessel with another 3.0x26mm stent in the mid rca vessel.The rca had excellent timi3 flow at the end of the procedure.The patient is alive with no further injury.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: annex d codes added.Correction: patient's sex and gender.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: there were no issues encountered with the cougar xt coronary guide wire.The new 3.0x38mm and 3.0x26mm stents used were both onyx frontier stents.The guide catheter used was a launcher device.The launcher guide catheter did not cause or contribute to the stent dislodgement.Update to patient information section a.3a and a.3b.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient presented to hospital with atypical chest pain and worsening angina.The mid rca had 70% stenosis, and there was severe diffuse disease throughout the vessel.The lesion had 100mm of its length treated.Intravascular ultrasound (ivus) was perfumed and there was 0% residual stenosis post intervention.Sections a.Patient information and b7.Relevant history updated.Image analysis: procedural images provided shows the treatment of the right coronary artery (rca).The mid vessel was pre-dilated prior to attempts to deliver the onyx frontier stent.The attempted delivery and dislodgement of the stent was not provided on the images, but the presence of a dislodged stent with the delivery catheter present in the guide catheter can be confirmed.The dislodged stent was at the ostium of the guide catheter suggesting that the deformation to the stent prevented it from re-entering the guide catheter.The dislodged stent was expanded by a series of balloons.The delivery of the balloons and the subsequent stents were supported by use of a guide extension catheter.It appears that the vessel morphology impacted in the unsuccessful delivery and dislodgement, but this cannot be confirmed.The launcher guide catheter did not appear to have an impact on the dislodgement.The stent deformation contributed to the dislodgement.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ONYX FRONTIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18736956
• MDR Text Key: 335697526
• Report Number: 9612164-2024-00847
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG30038UX
• Device Catalogue Number: ONYXNG30038UX
• Device Lot Number: 0012053271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Date Device Manufactured: 11/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 86 KG